FDA.reportPublic FDA data

KardiaBand System

Primary DI
B210AC0110
Brand
KardiaBand System
Company
Alivecor, Inc.
Model
AC-011
Device description
The Kardia Band System is a trans-telephonic (transmission by telephone) ECG(electrocardiogram) event recorder that records, stores and transfers single-channelelectrocardiogram rhythms.
Published
2024-03-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171816000Kardia Band SystemAliveCor, Inc.2017-11-16DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B210AC0110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(855) 338 8800support@alivecor.com
+4403333010433support@alivecor.com

Regulatory Flags#

DUNS number
078523613
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+AC-0192020-05-01
B210AC0290K1000AC-0292025-03-18
B210AC0210KardiaMobile CardAC-0212022-07-13
B210AC0090Kardia MobileAC-0092016-09-24
B210AC0270Kardia 12LAC-0272024-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
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